Nefazodone Hydrochloride

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• BOXED WARNING
• NEFAZODONE HYDROCHLORIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• PHARMACODYNAMICS
• PHARMACOKINETICS
• NEFAZODONE HYDROCHLORIDE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• LABORATORY TESTS
• DRUG INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• LABOR & DELIVERY
• NURSING MOTHERS
• PEDIATRIC USE
• NEFAZODONE HYDROCHLORIDE ADVERSE REACTIONS
• DRUG ABUSE AND DEPENDENCE
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• REFERENCES
• INFORMATION FOR PATIENTS
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

NEFAZODONE HYDROCHLORIDE DESCRIPTION

CLINICAL PHARMACOLOGY

PHARMACODYNAMICS

PHARMACOKINETICS

Uses

NEFAZODONE HYDROCHLORIDE CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

LABORATORY TESTS

DRUG INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

LABOR & DELIVERY

NURSING MOTHERS

PEDIATRIC USE

NEFAZODONE HYDROCHLORIDE ADVERSE REACTIONS

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

REFERENCES

INFORMATION FOR PATIENTS

• ●Yellowing of the skin or whites of eyes (jaundice)

• ●Unusually dark urine

• ●Loss of appetite that lasts several days or longer

• ●Nausea

• ●Abdominal (lower stomach) pain

• ●People who currently have liver problems should not take nefazodone.

• ●are taking Seldane(pimozide), used to treat Tourette(carbamazepine), used to control seizures.

• ●currently have liver problems.

• ●are taking or have taken within the last 14 days one of the medicines for depression known as monoamine oxidase inhibitors (MAOIs), such as Nardilor Parnate

• ●Be sure to tell your doctor if you

• ●are taking any other medicine, vitamin supplement, or herbal remedy, including those sold without a prescription (over-the-counter);

• ●have heart problems or have had a heart attack or stroke;

• ●have had manic episodes (extreme agitation or excitability);

• ●have ever attempted suicide;

• ●have had convulsions (seizures);

• ●are pregnant or breast-feeding.

• ●How should I take nefazodone?

• ●It may take a while for you to feel that nefazodone is working. You may not feel the full effect for several weeks. Once you feel better, it is important to keep taking nefazodone as directed by your doctor.

• ●If you miss a dose of nefazodone, skip that dose and continue with your regular schedule. Never take 2 doses at the same time.

• ●If you think that you have taken more nefazodone than prescribed, contact your doctor, local poison control center, or emergency room right away.

• ●What should I avoid while taking nefazodone?

• ●Before taking nefazodone, tell your doctor about any medicines you are taking, including vitamin supplements, herbal remedies, and any non-prescription (over-the-counter) medicines. Some of these medicines may affect how nefazodone works and should not be used in combination without talking to your doctor.

• ●Do not drink alcoholic beverages while taking nefazodone.

• ●Tell your doctor if you are pregnant, planning to become pregnant, or become pregnant while taking nefazodone. It is not known whether nefazodone can harm your unborn baby.

• ●Talk with your doctor before taking nefazodone if you are breast-feeding. It is not known whether nefazodone can pass through your breast milk to the baby.

• ●What are the possible side effects of nefazodone?

• ●Unusually dark urine

• ●Loss of appetite that lasts several days or longer

• ●Severe nausea

• ●Abdominal (lower stomach) pain

• ●Rash or hives

• ●Seizure (convulsion)

• ●Fainting

• ●Erection that lasts too long

• ●Tell your doctor right away about any side effects that you have or discomfort that you experience. Do not change your dose or stop taking nefazodone without talking with your doctor first.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION